Z-1022-2013Class II

Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase...

Name: Z-1022-2013 Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase...
Creator: Genetic Testing Institute,inc
Published: 2013-02-04
License: https://open.fda.gov/license/

Immucor GTI Diagnostics, Inc. / initiated 2013-02-04 / Terminated / root cause: manufacturing process

FDA source

Genetic Testing Institute,inc began a recall of Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA) on 2013-02-04. FDA classified it as Class II and gives the reason as "Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1022-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-04
Posted: 2013-03-28
Terminated: 2016-03-21
Recalling firm: Immucor GTI Diagnostics, Inc.
Product: Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Product code: LCO Platelet Factor 4 Radioimmunoassay
Reason for recall: Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or [email protected]. For questions regarding this recall call 262-754-1026.
Quantity in commerce: 386 kits (370 US, 16 OUS)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
Product codes and lots: Kit Lot Number 3000389

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1022-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1022-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

Product code LCO

K053559Class IIPf4 Enhanced Solid Phase ElisaGenetic Testing Institute / cleared 2006-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)